CR HD5.0 FLFS CASSETTE E1WE2

GUDID 05414904040539

CR HD5.0 FLFS CASSETTE 35X43CM

AGFA

Digital imaging cassette
Primary Device ID05414904040539
NIH Device Record Key8572b00e-d8e7-4d29-9a8c-5172cf4b12c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCR HD5.0 FLFS CASSETTE
Version Model NumberCR HD5.0 FLFS CASSETTE 35X43
Catalog NumberE1WE2
Company DUNS374444883
Company NameAGFA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)777-2432
Emailsalesinfo@agfa.com

Device Dimensions

Width43 Centimeter
Width43 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904040539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-14
Device Publish Date2016-09-01

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